Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is to confirm the long-term efficacy and safety of Rosuampin Tab. in patients with hypertension and hypercholesterolemia
All treatments, such as drug administration and clinical laboratory tests performed after Rosuampine administration, are performed according to the investigator's medical judgment, and information to be confirmed in this observational study is collected for up to 12 months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuampin 5/5mg (Rosuvastatin 5mg + Amlodipine 5mg) |
| ||
| Rosuampin 10/5mg (Rosuvastatin 10mg + Amlodipine 5mg) |
| ||
| Rosuampin 20/5mg (Rosuvastatin 20mg + Amlodipine 5mg) |
| ||
| Rosuampin 10/10mg (Rosuvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuampin 5/5mg, 10/5mg, 20/5mg, 10/10mg | Drug | Experimental only, not included active and placebo comparator |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence rate of MACCE(Major Adverse Cardiovascular and Cerebrovascular Events) | Baseline, 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to 6/12 months in SBP and DBP | Baseline, 6, 12 Months | |
| Percent change from baseline to 6/12 months in Lipid Profile (TC, LDL-C, TG, HDL-C) | Baseline, 6, 12 Months | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Patients with hypertension and hypercholesterolemia who are receiving Rosuampin medication or need Rosuampin medication according to the medical judgment of the investigator
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Moohyun Kim | Dong-A University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang-si | South Korea | ||||
| Dong-A University Hospital |
Not provided
Not provided
Not provided
Not provided
| Change from baseline to 6/12 months in hs-CRP |
| Baseline, 6, 12 Months |
| Change from baseline to 6/12 months in Diabetes indicator (Fasting Blood Glucose) | Baseline, 6, 12 Months |
| Change from baseline to 6/12 months in Diabetes indicator ( HbA1c) | Baseline, 6, 12 Months |
| Busan |
| 49201 |
| South Korea |
| Changwon Fatima Hospital | Changwon | South Korea |
| Gyeongsang National University Changwon Hospital | Changwon | South Korea |
| Daegu Catholic University Medical Center | Daegu | South Korea |
| Keimyung University Dongsan Medical Center | Daegu | South Korea |
| Yeungnam University Medical Center | Daegu | South Korea |
| Daejeon Eulji Medical Center Eulji University | Daejeon | South Korea |
| Myungji Hospital | Goyang-si | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Chosun University Hospital | Gwangju | South Korea |
| Bundang Jesaeng General Hospital | Gyeonggi-do | South Korea |
| Cha University Bundang Medical Center | Gyeonggi-do | South Korea |
| Hallym University Dongtan Sacred Heart Hospital | Gyeonggi-do | South Korea |
| Korea University Ansan Hospital | Gyeonggi-do | South Korea |
| National Health Insurance Service Ilsan Hospital | Gyeonggi-do | South Korea |
| Samsung Changwon Hospital | Gyeongsang | South Korea |
| Wonkwang University Hospital | Iksan | South Korea |
| Dongguk University Ilsan Hospital | Ilsan | South Korea |
| Inje University Ilsan Paik Hospital | Ilsan | South Korea |
| Inha University Hospital | Incheon | South Korea |
| Kwandong University International St.Mary'S Hospital | Incheon | South Korea |
| Dankook University Hospital | Jungnam | South Korea |
| Kwangju Veterance Hospital | Kwangju | South Korea |
| Pusan National University Hospital | Pusan | South Korea |
| Pusan National University Yangsan Hospital | Pusan | South Korea |
| Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| Ewha Womans University Mokdong Hospital | Seoul | South Korea |
| Ewha Womans University Seoul Hospital | Seoul | South Korea |
| Hallym University Medical Center | Seoul | South Korea |
| Kangdong Sacred Heart Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Korea University Guro Hospital | Seoul | South Korea |
| Kyung Hee University Medical Center | Seoul | South Korea |
| National Medical Center | Seoul | South Korea |
| Samsung Medical Center | Seoul | South Korea |
| Soon Chun Hyang University Hospital Cheonan | Taebuk | South Korea |
| Ulsan University | Ulsan | South Korea |
| Wonju Severance Christian Hospital | Wŏnju | South Korea |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided